Events

Recall of Device Recall Apligraf

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Organogenesis, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46250
  • Event Risk Class
    Class 2
  • Event Number
    Z-0675-2008
  • Event Initiated Date
    2007-12-26
  • Event Date Posted
    2008-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67037
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wound Dressing - Product Code MGR
  • Reason
    Contamination: apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at organogenesis. preliminary tests show a gram negative rod (bacillus) organism.
  • Action
    On 12/26/07, Organogenesis began to telephone the consignees to inform them of the recall. The firm sent a follow-up fax on 12/31/07 to all treating physicians who applied the product requesting patient status information. The Dear Doctor letter, dated December 27, 2007, was titled, "Subject: Potential contaminated Apligraf Units manufactured by Organogenesis, Inc." Consignees were instructed to return unused product, and monitor patients who received the Apligraf for adverse events.

Device

Device Recall Apligraf
  • Model / Serial
    Lot Numbers: GS0711.20.01.2A and GS0711.22.01.2A
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021
  • Manufacturer
    Organogenesis, Inc.

Manufacturer

Organogenesis, Inc.
  • Manufacturer Address
    Organogenesis, Inc., 150 Dan Road, Canton MA 02021-2820
  • Source
    USFDA